Recall record at a glance
| Official record | Z-2263-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | TriMed Inc. |
| Report date | Jun 27, 2018 |
| Recall initiation date | Apr 13, 2018 |
| Quantity | 323 |
| Location | Santa Clarita, CA, United States |
Official product description
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Why the product was recalled
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Distribution information
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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